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碱式硝酸铋的质量标准研究和探讨

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目的:优化完善碱式硝酸铋的质量标准。方法:比较国内外碱式硝酸铋质量标准,结合样品的实验结果,主要对其中文名称、鉴别项、检查项及含量测定进行增修订。结果:按拟定质量标准测定15批样品,含量的结果在71。8%~73。9%之间。建立的碱式硝酸铋质量标准已完成公示。结论:本标准的建立,将为碱式硝酸铋原料药的应用提供质量保障。
Investigation of the quality standard of bismuth subnitrate
Objective:To optimize the quality standard of bismuth subnitrate.Methods:In combination with the results of the experiment,the title,identification,test and assay items were added and revised by comparing domestic and international quality standards of bismuth subnitrate.Results:According to the proposed quality standard,the content of 15 batches of samples was 71.8%-73.9%.The drafted standard of bismuth subnitrate has been established.Conclusion:The established standard will provide the quality guarantee for the application of bismuth subnitrate in medicines.

bismuth subnitratequality standardsilverammonium saltsarsenicassay

邱娟、李玮玲

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广州市药品检验所,广州 510160

碱式硝酸铋 质量标准 银盐 铵盐 砷盐 含量测定

2024

中国药品标准
国家药典委员会

中国药品标准

影响因子:0.372
ISSN:1009-3656
年,卷(期):2024.25(6)